Challenges for Clinical Trials and Treating Patients With Cancer in Light of the Coronavirus

Randall A. Oyer, MD

Randall A. Oyer, MD

With the effects of the coronavirus disease 2019 (COVID-19) reaching every corner of the health care field, clinical trials for the development of life-saving cancer drugs have seen an enormous impact.

This week, the FDA released guidance for industry, investigators, and institutional review boards conducting trials of medical products during the pandemic. This includes considerations for ongoing trials, policies and procedures that can be put in place if they are not already, and what to do for trials that are impacted by COVID-19.¹

The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP) also issued interim guidance on how participating institutions should amend protocols and practices in their investigational and non-investigational new drug trials as well.²

In an interview withTargeted Oncology, Randall A. Oyer, MD, medical director at the Ann B. Barshinger Cancer Institute of Penn Medicine Lancaster General in Pennsylvania, and current president of the Association of Community Cancer Centers (ACCC), discussed how his institution is handling the pandemic while still accommodating patients who are already on clinical trials and making sure everyone stays safe.

TARGETED ONCOLOGY: Currently, are patients who have been enrolled and treated on clinical trials still receiving care?

Oyer:Yes; the clinical trials process, by its very nature, builds in an abundance of caution. What we’re seeing with COVID-19 is unprecedented, and what we’re hearing from our clinical trial leaders [is] put patients’ safety first.

We have had communications from the NCI and NCORP, from the cooperative groups, from our industry trial sponsors, and from in-house investigator-led trials. All of these communications put a premium on patients’ safety by continuing [to treat] patients on essential clinical trials, especially those who have the clear prospect of directly benefitting from the trial. Most sites are not opening new trials or enrolling new patients in trials.

TARGETED ONCOLOGY: Are any trials on hold right now due to the coronavirus?

Oyer:Not that I am aware of. The only postponement is the opening of new trials or the enrollment of new patients on trials. There aren’t any treatment trials that have taken a pause, but there will be activity that is focused on maintaining the care and integrity of trials for patients with life-threatening or serious conditions who are getting treatment that is likely to help them now.

TARGETED ONCOLOGY: Have any patients stopped coming into the clinic or been told to stay home?

Oyer:Yes, many, and that is one of the issues that is being addressed in these clinical trial guidance [documents]. They include potential inability of patients to get to a [treatment] center, local rules that may govern travel, who should come in, patients on a clinical trial who get sick, clinical trial staff that may get sick, or clinical trial staff that may need to be pulled to cover other areas when their coworkers are ill. All of those have played a role in what clinical trial leaders are outlining for how to cope with these disruptions.

TARGETED ONCOLOGY: What is happening with the clinical trials going on at the Ann B. Barshinger Cancer Institute?

Oyer:At my organization, we are going to suspend opening new clinical trials and we are not going to enroll new participants in existing clinical trials unless there’s someone with an acute cancer need for which one of our clinical trials is likely to make them better. We will certainly put patients first in that respect—somebody with an acute need—but we are not going to trials, but we are we going to enroll new patients on treatment trials if needed.

We’re going to focus our efforts right now on treatment trials rather than our prevention and registry trials. All of those [types of trials] are important across the board, and especially important in the community; but right now, everybody’s focused on treating patients who have acute needs and creating capacity and readiness for the unknown with people who are sick with COVID-19.

We have targeted [therapy] trials for lung, genitourinary, and breast cancer; we also have registry trials and long-term genetics trials. The latter would not be our immediate priority currently, as our [trials are being] funneled to acute needs. We are focused on the patients who are already on targeted therapy trials and making sure they get their treatments on time, we’re following their [adverse events] carefully, and that we’re doing their clinical follow-ups.

TARGETED ONCOLOGY: Have patients shown more hesitation to participate in trials recently?

Oyer:We haven’t seen that yet. Patients are expressing more hesitation about coming into the cancer centers and taking treatments that may impair their immune system when there’s clearly an immune threat that we’re all facing.

TARGETED ONCOLOGY:How has the day-to-day routine at your institution changed?

Oyer:Clinical trials are an important part of our cancer institute, but it’s only 1 part. You would get a sense of our focus by taking a look at our front door, where we have nurses, medical assistants, and other professionals stationed outside administering questionnaires, taking temperatures, and pulling aside or isolating people who may be at risk or who may be ill so that we can decrease the chance that others will get sick, including other patients and our staff. Our real focus is making sure that we are practicing social distancing in the cancer center, and that our employees are leading by example in the cancer center and in their personal lives.

Once somebody passes the questionnaire, screening, and temperature [phases of assessment], they’re given an arm band to show that they’ve been screened. Each one of our employees, [including me], goes through this process so that our patients and visitors can see that the employees have done the same thing. We have people stationed at the front door and we’ve locked door access at our back entrance, which connects to another part of our medical center and is a passageway for patients in gurneys and equipment. We have somebody stationed back there as well.

TARGETED ONCOLOGY:Have there been changes to how your staff conducts their daily practices?

Oyer:Within the cancer institute, we’re separating into teams so that the whole staff in 1 area doesn’t become [potentially affected by the virus] all at once. We hope it doesn’t happen at all; but if we have illnesses, [we don’t want it to affect] the whole of our team.

We’re dividing our teams up into shifts and looking at who can work from home. [We are also] making sure that anyone who has any type of fever, illness, or travel [history] self-excludes and doesn’t come to work, or that we are identifying them at the front door the same way we are with anyone else. We’re also keeping visitors out. We’ve canceled all meetings and we have [a travel ban in place]. All meetings and gatherings are done by video connection now. 

It almost seems like a backwards step [to divide into teams] because we put such attention on integrating all of our caregivers so that everybody knows each other, talks to each other, supports each other, shares information, and learns from each other. We divided our radiation team, our infusion nursing team, our medical oncology caregiver team, and so forth. We even took our conference rooms out of service and turned them into lunchrooms for various groups of people. Our cherished lunchroom space where people get to meet each other, relax, and get to know each is now divided up to try to keep people safe.

TARGETED ONCOLOGY:How does social distancing impact interactions with patients?

Oyer:We are trying to limit the number of staff members who need to serve a single patient; now 1 person takes a medical history and vital signs rather than splitting that between 2 providers. We are using gloves for that type of contact. When seeing a patient and, for example, doing a genetics consultation, we’re not shaking hands; we are sitting as far apart as possible at a conference table. We’ve all been prescreened. When I need to do a physical examination, I’m doing the requisite washing before and after and ask the patient’s permission before performing the actual physical examination. But this is medical care and if a person comes in thinking there’s a lump or a lymph node, we’re going to put that need first. We will wash our hands and keep our distance and do what’s necessary. It has impacted us; it’s slowed us down; it’s made things more awkward.

My genetics counselor and I needed to give some serious news to a patient, and it was the first day we had adopted a process of doing nonessential visits on the telephone. We delivered some news to a person who was crying [and] felt terrible not bringing them in, face-to-face, to let them know how much we cared, to offer them a tissue, to hold their hand, to give them a hug if that’s appropriate. She said “I can hear your concern in your voice on the phone, and I’m fine. I know that you did this for me. I would rather be there with you, but my husband and I feel safer at home and you’re explaining what we need to know on the telephone. We don’t need to be there.”

It’s a learning [curve] for all of us. We sit down, we make eye contact with people, we offer a pat on the arm, or a handhold, but it’s not essential. We have more pressing concerns; we have to take care of every individual as a person, but the care and safety allows us to take care of our caregivers and the population at large.

TARGETED ONCOLOGY:How have you seen the pandemic affecting other oncology groups, sponsors, and/or cooperative groups?

Oyer:I think there has been [consistent] communication. There are [also] some themes that we’re hearing. One is that patient safety comes first; second is that you need to follow your local guidelines; third is if somebody’s on treatment, please try to continue their treatment on schedule and as per protocol; and forth, it that there is a lot of guidance related to to changing the restrictions for how, where, and when care can be delivered.

The NCI and NCORP made some guidance for what happens if your center goes under, and how to transfer the patient to another qualified center that’s already enrolled so that the patient can get their care transferred to a different participating site.

Another [suggestion] is to continue to provide continuity of care that is generally restricted to the research staff by allowing non-research staff to [perform task]. For example, if I were enrolled as an investigator on a breast cancer trial and I became ill, my colleague who is not enrolled as an investigator on this trial, if she were still healthy, could treat my patients. She would be required to do everything that the protocol requires, but she would be able to register [patient data] even though she’s not part of the trial. Or perhaps if my research nurse is sick—somebody who’s been trained on a protocol—I could bring in another oncology nurse who had been vetted by the trial but who didn’t have the requisite training. I could oversee that the vital signs had been taken, the questions had been asked, and the blood had been drawn.

The same thing goes for clinical trials with laboratory and x-ray testing. These trials are very specific, so [ensuring] a qualified lab or radiology department is taking the x-rays [is important], but we have to be practical. If your lab is down, your radiology is interrupted. If a specific scan is needed for a milestone and can be obtained, or a scan is needed for an assessment of somebody who is sick, it will not be a protocol violation to do that at a site that’s not already licensed and part of the trial. These are practical and reasonable guidelines.

TARGETED ONCOLOGY:In what ways has treatment specifically changed or will change for patients due to the pandemic?

Oyer:Another issue that’s been [addressed] is regarding patients whose oral therapy is shipped to the pharmacist at a registered site. The pharmacist would log in the drug, verify the quantity and shipping conditions, and would dispense this to the patient. [Now], there will be a step allowing for the medication to be shipped to a patient’s home with some safety steps built in.

When a patient comes in to see me, if they can get their next 2 doses or if we anticipate that there might be trouble getting them in for the next visit, we would give 2 doses or maybe more. [Patients receiving an injectable medication may be given the drug] either at your site or at another qualified investigator site.

One of the cooperative groups, the Alliance Foundation, sent out communication that said you can make necessary changes in your process if you have to, [and to] submit them to your institutional review board to make sure there are no safety issues. You can do remote monitoring for a patient who has, for example, a milestone for which they would normally need to come into the clinic for; you need to find out how they’re feeling, whether they’re having any [adverse events] from the medication, or any other concerns. These are basically questionnaires.

We’re getting the guidance that it makes sense to do these remotely. There’s guidance around using local facilities that aren’t already part of the trial if you need to. They are collecting information and polling their members to find out what sort of disruption in plans are put in place so that we can all learn from each other.

TARGETED ONCOLOGY:Are there resources for patients or physicians to overcome challenges during the pandemic?

Oyer:Yes, we’re getting lots of guidance from the ACCC, American Society of Clinical Oncology (ASCO), and organizations that have already been through this. Additionally, we’re part of the Pennsylvania Health System, so we’re getting guidance for staffing, human resources—related issues, patient safety issues, isolation issues, and regarding how and where to test.

We’re trying to get information to our staff as quickly, succinctly, and accurately as possible, without overwhelming people with so many emails that they can’t keep up. We are trying to make sure that we’re not changing policies over and over unless it’s necessary, because it’s hard to keep up. I am, as the cancer institute’s leader, out on the floors, circulating with everybody to find out how the processes that we’ve put in place are working, learning from the people on the front line about what needs to be changed or improved, and checking in with people to make sure that they’re doing well, that they’re handling the stress, and to see what their concerns are and how we can address them.

TARGETED ONCOLOGY:What would you suggest to physicians who are unsure how to proceed with cancer treatment?

Oyer:Become a member of the ACCC, ASCO, or another trusted organization so that you can learn from the experience of others. Log on to your local department of health; don’t go it alone. Keep yourself and your staff safe so that you can continue to take care of patients.

<< View more resources regarding COVID-19

References:

1. FDA guidance on conduct of clinical trials of medical products during COVID-19 Pandemic. FDA website. fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic. Published March 18, 2020. Accessed March 19, 2020
2. Interim guidance for clinical trial activities affected by the new coronavirus. CTEP website. ctep.cancer.gov/content/docs/Memorandum_on_Interim_Guidance_for_Clinical_Trial_Activities_Affected_by_the_Novel_Coronavirus-3-13-2020.pdf. Published March 13, 2020. Accessed March 19, 2020.